Smith W T, Glaudin V, Panagides J, Gilvary E
Pacific N.W. Clinical Research Center, Portland, OR 97232.
Psychopharmacol Bull. 1990;26(2):191-6.
Patients (n = 150) were randomized to a 6-week, double-blind study to evaluate the relative efficacy and safety of mirtazapine, amitriptyline, and placebo in the treatment of major depressive disorder symptoms. Average daily modal doses were mirtazapine, 18 mg; amitriptyline, 111 mg; and placebo, 4.6 capsules. Mirtazapine- and amitriptyline-treated patients had statistically significantly greater mean Hamilton Rating Scale for Depression (HAM-D) score reductions (weekly visits 1, 2, 4, and endpoint) compared to placebo. These findings were supported by the Montgomery-Asberg Depression Rating Scale (MADRS); the Zung Self-rating Depression Scale (SDS); and the Clinical Global Impressions (CGI) scales. Somnolence and weight gain were the only adverse clinical experiences (ACEs) reported substantially more often by mirtazapine-treated patients than by those in the placebo group. However, more amitriptyline-treated patients reported decreased visual accommodation, dry mouth, dyspepsia, constipation, tachycardia, hypertension, hypotension, discoordination, dizziness, and tremor than mirtazapine- or placebo-treated patients. Results of this study indicate that mirtazapine is more effective than placebo in the treatment of these patients, and superior to amitriptyline in respect to anticholinergic and cardiovascular effects.
150名患者被随机分配至一项为期6周的双盲研究，以评估米氮平、阿米替林和安慰剂治疗重度抑郁症症状的相对疗效和安全性。平均每日标准剂量为：米氮平18毫克；阿米替林111毫克；安慰剂4.6粒胶囊。与安慰剂相比，接受米氮平和阿米替林治疗的患者在统计学上有显著更大幅度的汉密尔顿抑郁量表（HAM-D）评分降低（第1、2、4周就诊及研究终点）。这些发现得到了蒙哥马利-艾斯伯格抑郁量表（MADRS）、zung自评抑郁量表（SDS）以及临床总体印象（CGI）量表的支持。嗜睡和体重增加是米氮平治疗组患者比安慰剂组患者报告更频繁的仅有的不良临床体验（ACEs）。然而，与米氮平或安慰剂治疗组患者相比，更多接受阿米替林治疗的患者报告有视觉调节减退、口干、消化不良、便秘、心动过速、高血压、低血压、共济失调、头晕和震颤。本研究结果表明，米氮平治疗这些患者比安慰剂更有效，且在抗胆碱能和心血管效应方面优于阿米替林。
